For the first time, the Federal Drug Administration has approved a drug that tracks when you’ve taken it.

This digital drug is called Abilify MyCite, a sensor-equipped version of the Abilify drug that is already used to treat schizophrenia, bipolar and depression in adults. The digital sensor is made by a company called Proteus – and it’s the size of a grain of sand. This new Abilify MyCite “digital medicine system” includes a pill, a patch and a smartphone app. The pill contains the medicine and a sensor (made of metals that we can eat safely: silicon, copper and magnesium) that emits electric pulses when it hits the liquid in a patient’s stomach. The signals get picked up by a patch worn on the patient’s body, and the patch sends information to the patient’s smart phone. Doctors and family members or other caretakers designated by the patient can receive access to this information on a web portal to confirm a patient is adhering to their prescribed regimen.

Starting with Schizophrenia

The approval of Abilify MyCite comes on the heels of the patent expiration of the original Abilify antipsychotic drug. When Otsuka Pharmaceutical’s patent for the non-traceable form of Abilify expired in April 2015, the company sued the Federal Drug Administration (FDA) to extend their exclusive right to make the drug. Otsuka lost. Now, Otsuka and Proteus have approved the first traceable drug – transforming Abilify into Abilify MyCite. The companies have indicated that they will initially launch the traceable drug with a small number of healthcare providers. They argue that the traceability of the drug will help keep patients on their medications. In the case of schizophrenia, medication is an important part of living with severe forms of the chronic illness, and non-compliance is a reported problem. Many patients with schizophrenia struggle with homelessness and isolation from family and can relapse into debilitating symptoms without their medication.

Dr. Ghulam Surti, a clinical psychiatrist and the associate medical director for ambulatory emergency services at Butler Hospital, has prescribed the non-traceable form of the drug Abilify for years, both in a pill form and in a long-acting injection form. He is most concerned with patient education – how to talk to patients with schizophrenia about using medication to manage their chronic illnesses. Patients with schizophrenia often stop taking their prescribed doses when they see an improvement in symptoms, among other reasons, Dr. Surti says, but the illness does not go away. The injection form of Abilify works for a month and is already used as a solution for patients who are prone to missing pill doses. The greater need is not tracking, but good communication with patients.

“A lot of it is education,” Dr. Surti says. “The technology will help us tell whether the patient is taking the medication or not. But, if they decide not to take it, we will only find out. We cannot force the medicine on them.”

Dr. Peter Kramer, a professor emeritus of psychiatry and human behavior at Brown University, says that sensor-equipped medications can help patients share the responsibility of taking their medications with a doctor or family members. This can stop doctors from over-prescribing medications when it is clear patients are missing doses and can help families care for their loved ones from a distance. But he is “a little skeptical about psychiatry coming first” in the rollout of this new technology. Drawing attention to the recently expired patent for Abilify and to the potential costliness of the sensor-equipped drug, he says, “It is one of these initiatives that allows a drug company to extend a patent or create a very expensive version of a drug that is otherwise generic.” The companies have not yet indicated how much more expensive a sensor-equipped version of Abilify will be. High cost may compromise the drug’s ability to combat non-adherence if patients struggle to afford the drug or insurance companies do not cover it. A survey by the National Center for Health Statistics found that 8% of adults skip their prescribed medication because of high cost.

The unpleasant side-effects of Abilify causes some patients to opt out of taking the drug on their own. “With this sort of drug, it isn’t just that people forget it, it’s that they stop taking it. They don’t like it,” Dr. Kramer says. “In that context, monitoring can seem more coercive.” Otsuka has fielded a number of lawsuits over the impulse control problems associated with the drug, which comes with a strong FDA warning label. Some patients may also avoid seeing a doctor or using sensor-equipped medications for fear of being tracked, Dr. Kramer says.

A sensor-equipped drug would also add another, more invasive layer of monitoring to patients who are mandated to take their medications in the mental health court system – a situation that can arise with some schizophrenic patients who endanger themselves or others after failing to take their medication. “We have had patients who we know every time they stop the medicine, they are putting themselves at risk by staying in snow for a couple of days, having frostbite, not taking care of themselves, not eating, or harming others,” Dr. Surti says. “Sometimes we do take them to mental health court, and the judge makes an informed decision for the patient.” He says traceable medicine could be a helpful tool to evaluate patient compliance with these court orders, which are not permanent but must be periodically reevaluated by a judge. However, the injection form of Abilify that lasts for a month is already used in some of these cases and may be better than trying to track the patient’s compliance every day.

Dr. Kramer cautions that it can be unnerving for patients when a sensor-equipped medication becomes mandated by a court. A common symptom of schizophrenia is paranoia, the feeling of being tracked. Usually that feeling is symptomatic of the disease and unwarranted. He asks, “What does that do if someone who’s prone to paranoia is taking a tattle-tale pill, one that lets people know what’s going on in his daily behavior and in his body?”

Is the Information Worth the Invasion?

Perhaps this is the new frontier – big data produced by a next-generation fleet of sensor-equipped pharmaceuticals designed to keep us “on track” with our medications. Proteus, the company that manufacturers the sensors, is working toward an era of digital medicine in which we can monitor our vitals and drug intake in real time, one in which every pill includes a sensor. It is clear that not taking medication as prescribed is a common problem across fields of medicine – one that can put individual patients in danger and causes an estimated annual $290 billion of excess medical spending according to the New England Healthcare Institute. In the case of antibiotics, failure to complete full courses of medication can create antibiotic-resistant bacteria that do not respond to standard treatments, making treatment more costly and dangerous and diseases more deadly. But it is unclear whether Proteus’ sensors provide a solution to this crisis – or further complicate already difficult-to-manage relationships between doctors, patients and other actors in our healthcare system.

Especially for pills that change your brain chemistry, the potential for ethically compromising enforcement seems like a cloud on the sensor-filled horizon. One only has to imagine the tyrannical Nurse Rachett of One Flew Over the Cuckoo’s Nest staring at a monitor of digital drug information, created in real-time as the pills hit (or don’t hit in Randle Patrick McMurphy’s case) a patient’s stomach fluid, to begin feeling unnerved at the prospective Big Brother future of medicine. No patient can sneak away with a pill under their tongue. The Hollywood-ized example of scary mental health workers plays into a trope that does a disservice to the important patient care that happens in psychiatric institutions. But the image raises a pertinent point in the digital age of healthcare – more information is only as good as the people and institutions doing the monitoring and enforcement. This sensor-equipped pill can tell us whether a patient is taking it – but it is up to people to use that information in service of patients to create better healthcare outcomes.